U.S. patent application number 11/997976 was filed with the patent office on 2009-01-08 for method and apparatus for monitoring the condition of a patient with diabetes.
This patent application is currently assigned to ResMed Limited. Invention is credited to Donald Darkin, Carmel Therese Harrington, Klaus Henry Schindhelm.
Application Number | 20090007918 11/997976 |
Document ID | / |
Family ID | 38371123 |
Filed Date | 2009-01-08 |
United States Patent
Application |
20090007918 |
Kind Code |
A1 |
Darkin; Donald ; et
al. |
January 8, 2009 |
Method and Apparatus for Monitoring the Condition of a Patient with
Diabetes
Abstract
According to certain example embodiments of this invention,
there is provided an apparatus for treatment of a patient with both
sleep-disordered breathing and diabetes. A PAP device may be
configured to provide a supply of pressurized breathable gas. At
least one glycemia sensor also may be provided. A controller may be
operable to receive a signal from the at least one glycemia
detector and may be further operable to analyze the signal for an
indication of a glycemia abnormality (e.g., hypoglycemia,
hyperglycemia, diabetic coma, etc.). Optionally, when the signal
indicates that the patient is experiencing a diabetic event, an
alert may be generated and/or a drug delivery unit may administer
an appropriate treatment to the patient.
Inventors: |
Darkin; Donald; (Kenthurst,
AU) ; Schindhelm; Klaus Henry; (Glenhaven, AU)
; Harrington; Carmel Therese; (Coogee, AU) |
Correspondence
Address: |
NIXON & VANDERHYE, PC
901 NORTH GLEBE ROAD, 11TH FLOOR
ARLINGTON
VA
22203
US
|
Assignee: |
ResMed Limited
Bella Vista
AU
|
Family ID: |
38371123 |
Appl. No.: |
11/997976 |
Filed: |
February 16, 2007 |
PCT Filed: |
February 16, 2007 |
PCT NO: |
PCT/AU2007/000172 |
371 Date: |
February 5, 2008 |
Current U.S.
Class: |
128/205.25 ;
600/306; 600/365; 600/508; 600/529; 600/549; 604/66 |
Current CPC
Class: |
A61M 2230/65 20130101;
A61M 2230/10 20130101; A61M 16/0066 20130101; A61B 5/024 20130101;
A61M 16/0069 20140204; A61M 2205/583 20130101; A61M 2205/3561
20130101; A61B 5/369 20210101; A61M 2016/0036 20130101; A61M
2205/50 20130101; A61M 2230/50 20130101; A61M 2230/06 20130101;
A61M 16/024 20170801; A61M 16/06 20130101; A61M 2205/581 20130101;
A61B 5/14532 20130101; A61M 2230/42 20130101; A61M 2205/3553
20130101; A61M 2205/3584 20130101; A61M 15/00 20130101; A61M
16/0051 20130101; A61M 2230/201 20130101; A61B 5/0531 20130101;
A61M 16/0683 20130101 |
Class at
Publication: |
128/205.25 ;
600/306; 600/549; 600/508; 600/529; 600/365; 604/66 |
International
Class: |
A61M 16/10 20060101
A61M016/10; A61B 5/00 20060101 A61B005/00; A61B 5/01 20060101
A61B005/01; A61B 5/024 20060101 A61B005/024; A61B 5/08 20060101
A61B005/08; A61B 5/145 20060101 A61B005/145; A61M 37/00 20060101
A61M037/00 |
Foreign Application Data
Date |
Code |
Application Number |
Feb 17, 2006 |
AU |
2006900780 |
Claims
1. An apparatus for treatment of a patient with both
sleep-disordered breathing and diabetes comprising: a blower
configured to provide a supply of air at positive pressure; a
patient interface; headgear to hold the patient interface in
position in communication with a patient's airways; at least one
hypoglycemia sensor; an alarm; and a controller, wherein the
controller is programmed to receive a signal from the at least one
hypoglycemia detector, analyze the signal for indications of
hypoglycemia and upon detection of an indication of hypoglycemia
trigger the alarm.
2. The apparatus according to claim 1, wherein said at least one
hypoglycemia detector detects activation of the sympathetic nervous
system.
3. The apparatus according to claim 1, wherein said at least one
hypoglycemia detector detects at least one of: patient sweating,
temperature, heart rate, and respiration rate.
4. The apparatus according to claim 1, further comprising a flow
sensor in fluid communication with the patient interface.
5. The apparatus according to claim 1, wherein said alarm is a
buzzer.
6. The apparatus according to claim 1 wherein said alarm is sent to
a remote monitoring system.
7. An apparatus for treatment of a patient with both
sleep-disordered breathing and diabetes comprising: a PAP device
configured to provide a supply of pressurized breathable gas; at
least one glycemia sensor; and, a controller operable to receive a
signal from the at least one glycemia detector and further operable
to analyze the signal for an indication of a glycemia
abnormality.
8. The apparatus according to claim 7, wherein the at least one
glycemia sensor is one or more of: a transcutaneous blood sugar
level detector, a sensor for contact with mucosal regions of the
patient nares on a nasal prong of a mask connected to the PAP
device, and a sensor capable of measuring the patient's glucose
level by extracting a small amount of interstitial fluid that has
been removed from between the skin cells via a vacuum tube.
9. The apparatus according to claim 8, wherein said at least one
glycemia detector detects activation of the sympathetic nervous
system.
10. The apparatus according to claim 7, wherein said at least one
glycemia detector detects at least one of: patient sweating,
temperature, heart rate, and respiration rate.
11. The apparatus according to claim 7, wherein the controller is
further operable to sound an audible alert when the signal
indicates a glycemia abnormality.
12. The apparatus according to claim 7, wherein the controller is
further operable to send information about the patient treatment to
a remote monitoring station.
13. The apparatus according to claim 12, wherein the controller is
configured to send the information when the signal indicates one or
more of: patient hypoglycemia, hyperglycemia, and/or diabetic
coma.
14. The apparatus according to claim 7, further comprising a drug
delivery unit.
15. The apparatus according to claim 14, wherein the drug delivery
unit is configured to supply glucose and/or insulin to the
patient.
16. A method of treating a patient with both sleep-disordered
breathing and diabetes, the method comprising: providing a supply
of pressurized breathable gas to the patient; and, generating a
signal indicative of whether the patient is experiencing a diabetic
event.
17. The method according to claim 16, further comprising when the
signal indicates that the patient is experiencing a diabetic event,
activating an alert mechanism.
18. The method according to claim 17, wherein the step of
activating the alert mechanism is further practiced by sounding an
audible alarm.
19. The method according to claim 17, wherein the step of
activating the alert mechanism is further practiced by notifying a
remote monitoring station.
20. The method according to claim 16, further comprising when the
signal indicates that the patient is experiencing a diabetic event,
administering a corresponding treatment.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of Australian Patent
Application No. 2006 900780, filed Feb. 17, 2006, incorporated
herein by reference in its entirety.
FIELD OF THE INVENTION
[0002] Certain example embodiments described herein relate to the
monitoring of diabetic patients and, more particularly, certain
example embodiments described herein relate to monitoring diabetic
patients during sleep.
BACKGROUND OF THE INVENTION
[0003] Sleep-Disordered Breathing (SDB) is a general term for a
sleep disorder with apneas and hypopneas. Obstructive Sleep Apnea
(OSA) is an example of such a sleep disorder. Sullivan invented
treatment of OSA with nasal Continuous Positive Airway Pressure
(CPAP). See U.S. Pat. No. 4,944,310 (Sullivan). An apparatus for
CPAP treatment typically includes: (i) a source of air at positive
pressure, such as a blower, flow generator, or other positive
airway pressure (PAP) device; (ii) an air delivery conduit; and
(iii) a patient interface, such as a mask. The patient interface
typically is connected to the patient with headgear including, for
example, a series of elastic straps. At least a portion of the
headgear is in contact with the patient's skin, typically on the
patient's face. Patients wear the apparatus while sleeping.
[0004] A basic CPAP device may provide a supply of air at a
generally fixed pressure in the range of 4-20 cmH.sub.2O. A more
advanced CPAP device such as ResMed's AUTOSET SPIRIT can monitor
the patient's breathing, determine the shape of the breath
waveform, detect the presence of snoring, apneas, and hypopneas,
and also adjust the treatment pressure. See U.S. Pat. No. 5,704,345
(Berthon-Jones), the entire contents of which is incorporated
herein by reference.
[0005] Diabetes is a disease characterized by an elevated level of
glucose in the blood and in the urine. When blood sugar
extremes--both high (hyperglycemia) and low (hypoglycemia)--are not
treated, a patient can fall into a diabetic coma. The most common
cause of diabetic coma is hypoglycemia. This is caused by excessive
treatment with insulin relative to food intake and physical
activity. Research indicates that the frequency of severe
hypoglycemia is about 1.9 and 2.6 episodes per patient per year for
Type 1 and Type 2 diabetes patients, respectively, with
approximately 50% of these episodes occurring during sleep. There
is evidence that the fear of a hypoglycemic episode significantly
affects patient outcomes, such as glycemic control and management,
self-treatment modifications, and post-episode lifestyle
infringements (see Leiter et al. 2005, Canadian J Diabetes;
29:186-192). Recent studies have indicated that about 30% of
diabetic patients also have OSA (Meslier et al, Eur. Resp. J,
22(1):156-160), and there is emerging data indicating that
effective treatment of OSA with n-CPAP significantly improves
glucose metabolism.
[0006] Given that many diabetic patients will require treatment for
their OSA or other SDB, certain example embodiments of the present
invention are directed towards improving patient outcomes by
providing methods and apparatuses that can reduce the patients'
fear of hypoglycemia and/or other diabetes-related events.
SUMMARY OF THE INVENTION
[0007] One aspect of certain example embodiments of the invention
is to provide an apparatus comprising a hypoglycemia detector and
an action unit. In one form, the hypoglycemia detector monitors for
one or more of the following: shallow patient breathing, rapid
heart rate, temperature, and sweating and, when it detects
conditions indicative of hypoglycemia, it sends a signal to the
action unit. In one form, the action unit generates a local and/or
external alarm upon receipt of a signal from the detector.
[0008] According to certain example embodiments, an apparatus for
treatment of a patient with both sleep-disordered breathing and
diabetes is provided. Such an apparatus may comprise a blower
configured to provide a supply of air at positive pressure; a
patient interface; headgear to hold the patient interface in
position in communication with a patient's airways; at least one
hypoglycemia sensor; and an alarm. A controller also may be
provided, with the controller being programmed to receive a signal
from the at least one hypoglycemia detector, analyze the signal for
indications of hypoglycemia, and upon detection of an indication of
hypoglycemia trigger the alarm.
[0009] According to certain other example embodiments, an apparatus
for treatment of a patient with both sleep-disordered breathing and
diabetes is provided. A positive airway pressure (PAP) device
configured to provide a supply of pressurized breathable gas is
provided. At least one glycemia sensor also is provided. A
controller is operable to receive a signal from the at least one
glycemia detector and is further operable to analyze the signal for
an indication of a glycemia abnormality (e.g., hypoglycemia,
hyperglycemia, diabetic coma, etc.).
[0010] According to still other embodiments, a method of treating a
patient with both sleep-disordered breathing and diabetes is
provided. A supply of pressurized breathable gas is provided to the
patient. A signal indicative of whether the patient is experiencing
a diabetic event is generated. Optionally, when the signal
indicates that the patient is experiencing a diabetic event, an
alert mechanism may be activated and/or a corresponding treatment
may be administered.
[0011] Other aspects, features, and advantages of this invention
will become apparent from the following detailed description when
taken in conjunction with the accompanying drawings, which are a
part of this disclosure and which illustrate, by way of example,
principles of this invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] The accompanying drawings facilitate an understanding of the
various embodiments of this invention. In such drawings:
[0013] FIG. 1 is an apparatus including a positive airway pressure
(PAP) device, patient interface, headgear, and glucose sensor, in
accordance with an example embodiment;
[0014] FIG. 2 is an apparatus for treating a patient with both
sleep-disordered breathing and diabetes, in accordance with another
example embodiment; and,
[0015] FIG. 3 is an illustrative flowchart showing a procedure for
treating a patient with both sleep-disordered breathing and
diabetes.
DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS
[0016] In one example embodiment an apparatus 10 includes a patient
interface--for example, a nasal mask 20--connected to a positive
airway pressure (PAP) device 30 including a flow sensor 40. Patient
breathing in the nasal mask 20 is detected by the flow sensor 40,
which generates a flow signal that is sent to the controller 50.
The controller 50 includes a microprocessor or any suitable
combination of hardware, software, or other programmed logic
circuitry operable to analyze signals from a range of inputs. In
the controller 50, components of the flow signal caused by leak may
be filtered (e.g., reduced and/or removed), thereby providing a
respiratory flow signal. The heart rate is detected from small
oscillations in the flow signal occurring in a frequency band
around 1 Hz. Ventilation is determined from the respiratory flow
signal.
[0017] In certain example embodiments, the apparatus 10 may include
a detector 60 built into the headgear 70. In certain example
embodiments, the headgear 70 may further comprise skin conductivity
sensors in one or more locations in the headgear 70. Such skin
conductivity sensors may be arranged so as to be in contact with
the skin. Patient sweating can be detected as a change in skin
conductivity. In certain example embodiments, the headgear 70 may
further include skin temperature sensors. More generally, in
certain example embodiments, sensors may be built into and/or
otherwise connected to the headgear 70 to detect indications of
sympathetic nervous system activation. See, for example, U.S.
Publication No. 2006/0100538, the entire contents of which are
incorporated herein by reference.
[0018] In certain example embodiments, a hypoglycemic detector may
be provided, which may include a transcutaneous blood sugar level
detector 80 connected to the controller 50 via an interface 90. In
certain example embodiments, the blood sugar level detector 80 may
include a sensor on a nasal prong for contact with the mucosal
regions of the nares. In certain other example embodiments, the
sensor may be suitable to be used on a limb of a patient, such as
an arm.
[0019] In certain example embodiments, the hypoglycemic detector
may measure the glucose level in a small amount of interstitial
fluid that has been removed from between the skin cells by a vacuum
action.
[0020] In certain example embodiments, the hypoglycemic detector
may use a plethysmogram to detect a range of patient parameters
including heart rate. See, for example, PCT Patent Application No.
PCT/AU2005/001543 (Martin & Oates), the entire contents of
which is hereby incorporated herein by reference.
[0021] In certain example embodiments, the hypoglycemic detector
may use an electroencephalogram (EEG) to determine when a patient
is in a coma. The EEG sensors may be built into the headgear, for
example, by using a device manufactured by Advanced Brain
Monitoring, Inc.
[0022] In certain example embodiments, an action unit is provided,
which includes a buzzer that generates an audible signal when
hypoglycemia is detected by the detector. In certain other example
embodiments, the action unit is connected to a remote monitoring
station via a network (e.g., the Internet, a LAN, a WAN, etc.).
When hypoglycemia is detected, the action unit may send a signal to
the remote monitoring station to indicate that the patient is
potentially suffering from a diabetic coma. It will be appreciated
that the alarm may include one or more of an audible and/or visual
alert, a remote notification, an automated delivery of a treatment
(e.g., insulin), etc.
[0023] In certain example embodiments, the action unit may further
include a drug delivery unit that can supply glucose or insulin, as
appropriate, to the person. For example, patients suffering from
hypoglycemia may be given glucose, hyperglycemic patients may
receive oral insulin via the mask, etc.
[0024] Similar to FIG. 1, FIG. 2 is an apparatus for treating a
patient with both sleep-disordered breathing and diabetes, in
accordance with another example embodiment. As shown in FIG. 2, a
drug delivery unit 100 may be provided to the apparatus which is
shown without the headgear 70. Based on the signals at one or more
of the flow sensor 40, the blood sugar level detector 80, etc., the
controller 50 may determine that a diabetic event (e.g.,
hypoglycemia, hyperglycemia, diabetic coma, etc.), apnea or
hypopnea event, and/or other events has/have occurred. In response,
the controller 50 may, via the interface 40, instruct the drug
delivery unit 100 to supply a treatment to the patient. For
example, oral insulin, glucose, etc. may be administered
automatically (e.g., via a vapor and/or aerosol delivery) and/or
recommended for administration by a human user.
[0025] FIG. 3 is an illustrative flowchart showing a procedure for
treating a patient with both sleep-disordered breathing and
diabetes. In FIG. 3, a patient is treated for sleep-disordered
breathing in step S302. Monitoring for hypoglycemia and/or
hyperglycemia is performed in step S304. The monitoring process may
include gathering relevant signals (e.g., patient sweat, heart
rate, EEG signals, breath, snore, blood sugar level, etc.) and/or
filtering such signals when necessary. If a diabetic event is not
detected in step S306, the normal treatment and monitoring
continues. However, if a diabetic event is detected in step S306,
an alert mechanism is activated in step S308. As noted above, the
alert mechanism may include, for example, activating an
audio/visual alarm, notifying a monitoring station that may be
located remote from the patient, etc. Additionally, an appropriate
treatment may be administered in step S310.
[0026] Given these techniques, patients suffering from both OSA
and/or other sleep-disordered breathing and diabetes who are being
treated with nasal CPAP can sleep with the assurance that should
they begin to become hypoglycemic, their CPAP device will detect
this and raise an alarm and/or take a suitable counteraction.
[0027] While the invention has been described in connection with
what are presently considered to be the most practical and
preferred embodiments, it is to be understood that the invention is
not to be limited to the disclosed embodiments, but on the
contrary, is intended to cover various modifications and equivalent
arrangements included within the spirit and scope of the invention.
Also, the various embodiments described above may be implemented in
conjunction with other embodiments, e.g., aspects of one embodiment
may be combined with aspects of another embodiment to realize yet
other embodiments.
[0028] Also, the various embodiments described above may be
implemented in conjunction with other embodiments, e.g., aspects of
one embodiment may be combined with aspects of another embodiment
to realize yet other embodiments. In addition, while the invention
has particular application to patients who suffer from OSA, it is
to be appreciated that patients who suffer from other illnesses
(e.g., congestive heart failure, diabetes, morbid obesity, stroke,
barriatric surgery, etc.) can derive benefit from the above
teachings. Moreover, the above teachings have applicability with
patients and non-patients alike in non-medical applications.
* * * * *